[Federal Register: August 13, 2007 (Volume 72, Number 155)]

[Proposed Rules]              

[Page 45201-45213]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13au07-23]                        

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Centers for Medicare & Medicaid Services

 

42 CFR Parts 440 and 441

 

[CMS 2261-P]

RIN 0938-A081

 

 

Medicaid Program; Coverage for Rehabilitative Services

 

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

 

ACTION: Proposed rule.

 

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SUMMARY: This proposed rule would amend the definition of Medicaid

rehabilitative services in order to provide for important beneficiary

protections such as a person-centered written rehabilitation plan and

maintenance of case records. The proposed rule would also ensure the

fiscal integrity of claimed Medicaid expenditures by clarifying the

service definition and providing that Medicaid rehabilitative services

must be coordinated with but do not include services furnished by other

programs that are focused on social or educational development goals

and available as part of other services or programs. These services and

programs include, but are not limited to, foster care, child welfare,

education, child care, prevocational and vocational services, housing,

parole and probation, juvenile justice, public guardianship, and any

other non-Medicaid services from Federal, State, or local programs.

 

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. on October 12, 2007.

 

ADDRESSES: In commenting, please refer to file code CMS-2261-P. Because

of staff and resource limitations, we cannot accept comments by

facsimile (FAX) transmission.

    You may submit comments in one of four ways (no duplicates,

please):

    1. Electronically. You may submit electronic comments on specific

issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click

 on the link ``Submit electronic comments on CMS regulations with an open

comment period.'' (Attachments should be in Microsoft Word, WordPerfect,

or Excel; however, we prefer Microsoft Word.)

    2. By regular mail. You may mail written comments (one original and

two copies) to the following address ONLY: Centers for Medicare &

Medicaid Services, Department of Health and Human Services, Attention:

CMS-2261-P, P.O. Box 8018, Baltimore, MD 21244-8018.

    Please allow sufficient time for mailed comments to be received

before the close of the comment period.

    3. By express or overnight mail. You may send written comments (one

original and two copies) to the following address ONLY: Centers for

Medicare & Medicaid Services, Department of Health and Human Services,

Attention: CMS-2261-P, Mail Stop C4-26-05, 7500 Security Boulevard,

Baltimore, MD 21244-1850.

    4. By hand or courier. If you prefer, you may deliver (by hand or

courier) your written comments (one original and two copies) before the

close of the comment period to one of the following addresses. If you

intend to deliver your comments to the Baltimore address, please call

telephone number (410) 786-3685 in advance to schedule your arrival

with one of our staff members.

 

Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,

Washington, DC 20201; or

7500 Security Boulevard, Baltimore, MD 21244-1850.

 

    (Because access to the interior of the HHH Building is not readily

available to persons without Federal Government identification,

commenters are encouraged to leave their comments in the CMS drop slots

located in the main lobby of the building. A stamp-in clock is

available for persons wishing to retain a proof of filing by stamping

in and retaining an extra copy of the comments being filed.)

    Comments mailed to the addresses indicated as appropriate for hand

or courier delivery may be delayed and received after the comment

period.

    Submission of comments on paperwork requirements. You may submit

comments on this document's paperwork requirements by mailing your

comments to the addresses provided at the end of the ``Collection of

Information Requirements'' section in this document.

    For information on viewing public comments, see the beginning of

the SUPPLEMENTARY INFORMATION section.

 

FOR FURTHER INFORMATION CONTACT: Maria Reed, (410) 786-2255 or Shawn

Terrell, (410) 786-0672.

 

SUPPLEMENTARY INFORMATION:

    Submitting Comments: We welcome comments from the public on all

issues set forth in this rule to assist us in fully considering issues

and developing policies. You can assist us by referencing the file code

CMS-2261-P and the specific ``issue identifier'' that precedes the

section on which you choose to comment.

    Inspection of Public Comments: All comments received before the

close of the comment period are available for viewing by the public,

including any personally identifiable (for example, names, addresses,

social security numbers, and medical diagnoses) or confidential

business information (including proprietary information) that is

included in a comment. We post all comments received before the close

of the comment period on the following Web site as soon as possible

after they have been received: http://www.cms.hhs.gov/eRulemaking.

 

Click on the link ``Electronic Comments on CMS Regulations'' on that

Web site to view public comments.

    Comments received timely will also be available for public

inspection as they are received, generally beginning approximately 3

weeks after publication of a document, at the headquarters of the

Centers for Medicare & Medicaid Services, 7500 Security Boulevard,

Baltimore, Maryland 21244, Monday through Friday of each week from 8:30

a.m. to 4 p.m. To schedule an appointment to view public comments,

phone 1-800-743-3951.

 

I. Background

 

A. Overview

 

    Section 1905(a)(13) of the Social Security Act (the Act) includes

rehabilitative services as an optional Medicaid State plan benefit.

Current Medicaid regulations at 42 CFR 440.130(d) provide a broad

definition of rehabilitative services. Rehabilitative services are

defined as ``any medical or remedial services recommended by a

physician or other licensed practitioner of the healing arts, within

the scope of his or her practice under State law, for maximum reduction

of physical or mental disability and restoration of a recipient to his

best possible functional level.'' The broad general language in this

regulatory definition has afforded States considerable flexibility

under their State plans to meet the needs of their State's Medicaid

population.

    Over the years the scope of services States have provided under the

rehabilitation benefit has expanded from physical rehabilitative

services to also include mental health and substance abuse treatment

rehabilitative services. For example, services currently provided by

States under the rehabilitative benefit include services aimed at

improving physical disabilities, including physical, occupational, and

speech therapies; mental health services, such as individual and group

therapy, psychosocial therapy services; and services for substance-

related disorders (for example, substance use disorders and substance

induced disorders). These Medicaid services may be delivered through

various models of care and in a variety of settings.

    The broad language of the current statutory and regulatory

definition has, however, had some unintended consequences. It has also

led to some confusion over whether otherwise applicable statutory or

regulatory provider standards would apply under the rehabilitative

services benefit.

    As the number of States providing rehabilitative services has

increased, some States have viewed the rehabilitation benefit as a

``catch-all'' category to cover services included in other Federal,

State and local programs. For example, it appears some States have used

Medicaid to fund services that are included in the provision of foster

care and in the Individuals with Disabilities Education Improvement Act

(IDEA). Our audit reviews have recently revealed that Medicaid funds

have also been used to pay for behavioral treatment services in

``wilderness camps,'' juvenile detention, and similar facilities where

youth are involuntarily confined. These facilities are under the domain

of the juvenile justice or youth systems in the State, rather than

Medicaid, and there is no assurance that the claimed services reflect

an independent evaluation of individual rehabilitative needs.

    This proposed regulation is designed to clarify the broad general

language of the current regulation to ensure that rehabilitative

services are provided in a coordinated manner that is in the best

interest of the individuals, are limited to rehabilitative purposes and

are furnished by qualified providers. This proposed regulation would

rectify the improper reliance on the Medicaid rehabilitation benefit

for services furnished by other programs that are focused on social or

educational development goals in programs other than Medicaid.

    This proposed regulation would provide guidance to ensure that

services claimed under the optional Medicaid rehabilitative benefit are

in fact rehabilitative out-patient services, are furnished by qualified

providers, are

 

[[Page 45203]]

 

provided to Medicaid eligible individuals according to a goal-oriented

rehabilitation plan, and are not for services that are included in

programs with a focus other than that of Medicaid.

 

B. Habilitation Services

 

    Section 6411(g) of the Omnibus Budget Reconciliation Act of 1989

(OBRA 89) prohibits us from taking adverse action against States with

approved habilitation provisions pending the issuance of a regulation

that ``specifies types of day habilitation services that a State may

cover under paragraphs (9) (clinic services) or (13) (rehabilitative

services) of section 1905(a) of the Act on behalf of persons with

mental retardation or with related conditions.'' We believe that

issuance of a final rule based on this proposed rule will satisfy this

condition. We intend to work with those States that have habilitation

programs under the clinic services or rehabilitative services benefits

in their State plans to transition to appropriate Medicaid coverage

authorities, such as section 1915(c) waivers or the Home and Community-

Based Services State plan option under section 1915 (i) of the Deficit

Reduction Act (DRA) of 2005 (Pub. L. 107-171), enacted on February 8,

2006.

 

II. Provisions of the Proposed Rule

 

    [If you choose to comment on issues in this section, please include

the caption ``PROVISIONS OF THE PROPOSED REGULATIONS'' at the beginning

of your comments.]

 

A. Definitions

 

    In 440.130(d)(1), we propose to define the terms used in this rule,

as listed below:

     Recommended by a physician or other licensed practitioner

of the healing arts.

     Other licensed practitioner of the healing arts.

     Qualified providers of rehabilitative services.

     Under the direction of.

     Written rehabilitation plan.

     Restorative services.

     Medical services.

     Remedial services.

    In Sec.  440.130(d)(1)(iii), we would define ``qualified providers

of rehabilitative services'' to require that individuals providing

rehabilitative services meet the provider qualification requirements

applicable to the same service when it is furnished under other benefit

categories. Further, the provider qualifications must be set forth in

the Medicaid State plan. These qualifications may include education,

work experience, training, credentialing, supervision and licensing,

that are applied uniformly. Provider qualifications must be reasonable

given the nature of the service provided and the population being

served. We require uniform application of these qualifications to

ensure the individual free choice of qualified providers, consistent

with section 1902(a)(23) of the Act.

    Under this proposed definition, if specific provider qualifications

are set forth elsewhere in subpart A of part 440, those provider

qualifications take precedence when those services are provided under

the rehabilitation option. Thus, if a State chooses to provide the

various therapies discussed at Sec.  440.110 (physical therapy,

occupational therapy, speech, language and hearing services) under

Sec.  440.130(d), the requirements of Sec.  440.110 applicable to those

services would apply. For example, speech therapy is addressed in

regulation at Sec.  440.110(c) with specific provider requirements for

speech pathologists and audiologists that must be met. If a State

offers speech therapy as a rehabilitative service, the specific

provider requirements at Sec.  440.110(c) must be met. It should be

noted that the definition of Occupational Therapy in Sec.  440.110 is

not correct insofar as the following--Occupational Therapists must be

certified through the National Board of Certification for Occupational

Therapy, not the American Occupational Therapy Association.

    We are proposing a definition of the term ``under the direction

of'' because it is a key issue in the provision of therapy services

through the rehabilitative services benefit. Therapy services may be

furnished by or ``under the direction of'' a qualified provider under

the provisions of Sec.  440.110. We are proposing to clarify that the

term means that the therapist providing direction is supervising the

individual's care which, at a minimum, includes seeing the individual

initially, prescribing the type of care to be provided, reviewing the

need for continued services throughout treatment, assuming professional

responsibility for services provided, and ensuring that all services

are medically necessary. The term ``under the direction of'' requires

each of these elements; in particular, professional responsibility

requires face-to-face contact by the therapist at least at the

beginning of treatment and periodically thereafter. Note that this

definition applies specifically to providers of physical therapy,

occupational therapy, and services for individuals with speech, hearing

and language disorders. This language is not meant to exclude

appropriate supervision arrangements for other rehabilitative services.

 

B. Scope of Services

 

    Consistent with the provision of section 1905(a)(13) of the Act, we

have retained the current definition of rehabilitative services in

Sec.  440.130(d)(2) as including ``medical or remedial services

recommended by a physician or other licensed practitioner of the

healing arts, within the scope of his practice under State law, for

maximum reduction of physical or mental disability and restoration of a

recipient to his best possible functional level.'' We would, however,

clarify that rehabilitative services do not include room and board in

an institution, consistent with the longstanding CMS interpretation

that section 1905(a) of the Act has specifically identified

circumstances in which Medicaid would pay for coverage of room and

board in an inpatient setting. This interpretation was upheld in Texas

v. U.S. Dep't Health and Human Servs., 61 F.3d 438 (5th Cir. 1995).

 

C. Written Rehabilitation Plan

 

    We propose to add a new requirement, at Sec.  440.130(d)(3), that

covered rehabilitative services for each individual must be identified

under a written rehabilitation plan. This rehabilitation plan would

ensure that the services are designed and coordinated to lead to the

goals set forth in statute and regulation (maximum reduction of

physical or mental disability and restoration to the best possible

functional level). It would ensure transparency of coverage and medical

necessity determinations, so that the beneficiary, and family or other

responsible individuals, would have a clear understanding of the

services that are being made available to the beneficiary. In all

situations, the ultimate goal is to reduce the duration and intensity

of medical care to the least intrusive level possible which sustains

health. The Medicaid goal is to deliver and pay for the clinically-

appropriate, Medicaid-covered services that would contribute to the

treatment goal. It is our expectation that, for persons with mental

illnesses and substance-related disorders, the rehabilitation plan

would include recovery goals. The rehabilitation plan would establish a

basis for evaluating the effectiveness of the care offered in meeting

the stated goals. It would provide for a process to involve the

beneficiary, and family or other responsible individuals, in the

overall management of rehabilitative care. The rehabilitation plan

would also

 

[[Page 45204]]

 

document that the services have been determined to be rehabilitative

services consistent with the regulatory definition, and will have a

timeline, based on the individual's assessed needs and anticipated

progress, for reevaluation of the plan, not longer than one year. It is

our expectation that the reevaluation of the plan would involve the

beneficiary, family, or other responsible individuals and would include

a review of whether the goals set forth in the plan are being met and

whether each of the services described in the plan has contributed to

meeting the stated goals. If it is determined that there has been no

measurable reduction of disability and restoration of functional level,

any new plan would need to pursue a different rehabilitation strategy

including revision of the rehabilitative goals, services and/or

methods. It is important to note that this benefit is not a custodial

care benefit for individuals with chronic conditions but should result

in a change in status. The rehabilitation plan should identify the

rehabilitation objectives that would be achieved under the plan in

terms of measurable reductions in a diagnosed physical or mental

disability and in terms of restored functional abilities. We recognize,

however, that rehabilitation goals are often contingent on the

individual's maintenance of a current level of functioning. In these

instances, services that provide assistance in maintaining functioning

may be considered rehabilitative only when necessary to help an

individual achieve a rehabilitation goal as defined in the

rehabilitation plan. Services provided primarily in order to maintain a

level of functioning in the absence of a rehabilitation goal are not

rehabilitation services.

    It is our further expectation that the rehabilitation plan be

reasonable and based on the individual's diagnosed condition(s) and on

the standards of practice for provisions of rehabilitative services to

an individual with the individual's condition(s). The rehabilitation

plan is not intended to limit or restrict the State's ability to

require prior authorization for services. The proposed requirements

state that the written rehabilitation plan must:

     Be based on a comprehensive assessment of an individual's

rehabilitation needs including diagnoses and presence of a functional

impairment in daily living;

     Be developed by qualified provider(s) working within the

State scope of practice acts with input from the individual,

individual's family, the individual's authorized health care decision

maker and/or persons of the individual's choosing;

     Ensure the active participation of the individual,

individual's family, the individual's authorized health care decision

maker and/or persons of the individual's choosing in the development,

review and modification of these goals and services;

     Specify the individual's rehabilitation goals to be

achieved, including recovery goals for persons with mental health and/

or substance related disorders;

     Specify the physical impairment, mental health and/or

substance related disorder that is being addressed;

     Identify the medical and remedial services intended to

reduce the identified physical impairment, mental health and/or

substance related disorder;

     Identify the methods that would be used to deliver

services;

     Specify the anticipated outcomes;

     Indicate the frequency, amount and duration of the

services;

     Be signed by the individual responsible for developing the

rehabilitation plan;

     Indicate the anticipated provider(s) of the service(s) and

the extent to which the services may be available from alternate

provider(s) of the same service;

     Specify a timeline for reevaluation of the plan, based on

the individual's assessed needs and anticipated progress, but not

longer than one year;

     Document that the individual or representative

participated in the development of the plan, signed the plan, and

received a copy of the rehabilitation plan; and

     Document that the services have been determined to be

rehabilitative services consistent with the regulatory definition.

    We believe that a written rehabilitation plan would ensure that

services are provided within the scope of the rehabilitative services

and would increase the likelihood that an individual's disability would

be reduced and functional level restored. In order to determine whether

a specific service is a covered rehabilitative benefit, it is helpful

to scrutinize the purpose of the service as defined in the care plan.

    For example, an activity that may appear to be a recreational

activity may be rehabilitative if it is furnished with a focus on

medical or remedial outcomes to address a particular impairment and

functional loss. Such an activity, if provided by a Medicaid qualified

provider, could address a physical or mental impairment that would help

to increase motor skills in an individual who has suffered a stroke, or

help to restore social functioning and personal interaction skills for

a person with a mental illness.

    We are proposing to require in Sec.  440.130(d)(3)(iii) that the

written rehabilitation plan include the active participation of the

individual (or the individual's authorized health care decision maker)

in the development, review, and reevaluation of the rehabilitation

goals and services. We recommend the use of a person-centered planning

process. Since the rehabilitation plan identifies recovery-oriented

goals, the individual must be at the center of the planning process.

 

D. Impairments to be Addressed

 

    We propose in Sec.  440.130(d)(4) that rehabilitative services

include services provided to an eligible individual to address the

individual's physical needs, mental health needs, and/or substance-

related disorder treatment needs. Because rehabilitative services are

an optional service for adults, a State has flexibility to determine

whether rehabilitative services would be limited to certain

rehabilitative services (for example, only physical rehabilitative

services) or will include rehabilitative treatment for mental health or

substance-related disorders as well.

    Provision of rehabilitative services to individuals with mental

health or substance-related disorders is consistent with the

recommendations of the New Freedom Commission on Mental Health. The

Commission challenged States, among others, to expand access to quality

mental health care and noted that States are at the very center of

mental health system transformation. Thus, while States are not

required to provide rehabilitative services for treatment of mental

health and substance-related disorders, they are encouraged to do so.

The Commission noted in its report that, ``[m]ore individuals would

recover from even the most serious mental illnesses and emotional

disturbances if they had earlier access in their communities to

treatment and supports that are evidence-based and tailored to their

needs.''

    Under existing provisions at Sec.  440.230(a), States are required

to provide in the State plan a detailed description of the services to

be provided. In reviewing a State plan amendment that proposes

rehabilitative services, we would consider whether the proposed

services are consistent with the requirements in Sec.  440.130(d) and

section 1905(a)(13) of the Act. We would also consider whether the

proposed scope of rehabilitative services

 

[[Page 45205]]

 

is ``sufficient in amount, duration and scope to reasonably achieve its

purpose'' as required at Sec.  440.230(b). For that analysis, we will

review whether any assistive devices, supplies, and equipment necessary

to the provision of those services are covered either under the

rehabilitative services benefit or elsewhere under the plan.

 

E. Settings

 

    In Sec.  440.130(d)(5), consistent with the provisions of section

1905(a)(13) of the Act, we propose that rehabilitative services may be

provided in a facility, home, or other setting. For example,

rehabilitative services may be furnished in freestanding outpatient

clinics and to supplement services otherwise available as an integral

part of the services of facilities such as schools, community mental

health centers, or substance abuse treatment centers. Other settings

may include the office of qualified independent practitioners, mobile

crisis vehicles, and appropriate community settings. The State has the

authority to determine in which settings a particular service may be

provided. While services may be provided in a variety of settings, the

rehabilitative services benefit is not an inpatient benefit.

Rehabilitative services do not include room and board in an

institutional, community or home setting.

 

F. Requirements and Limitations for Rehabilitative Services

 

1. Requirements for Rehabilitative Services

    In Sec.  441.45(a), we set forth the assurances required in a State

plan amendment that provides for rehabilitative services in this

proposed rule. In Sec.  441.45(b) we set forth the expenditures for

which Federal financial participation (FFP) would not be available.

    As with most Medicaid services, rehabilitative services are subject

to the requirements of section 1902(a) of the Act. These include

statewideness at section 1902(a)(1) of the Act, comparability at

section 1902(a)(10)(B), and freedom of choice of qualified providers at

section 1902(a)(23) of the Act. Accordingly, at Sec.  441.45(a)(1), we

propose to require that States comport with the listed requirements.

    At Sec.  441.45(a)(2), we propose to require that the State ensure

that rehabilitative services claimed for Medicaid payment are only

those provided for the maximum reduction of physical or mental

disability and restoration of the individual to the best possible

functional level.

    In Sec.  441.45(a)(3) and (a)(4), we propose to require that

providers of the rehabilitative services maintain case records that

contain a copy of the rehabilitation plan. We also propose to require

that the provider document the following for all individuals receiving

rehabilitative services:

     The name of the individual;

     The date of the rehabilitative service or services

provided;

     The nature, content, and units of rehabilitative services

provided; and

     The progress made toward functional improvement and

attainment of the individual's goals.

    We believe this information is necessary to establish an audit

trail for rehabilitative services provided, and to establish whether or

not the services have achieved the maximum reduction of physical or

mental disability, and to restore the individual to his or her best

possible functional level.

    A State that opts to provide rehabilitative services must do so by

amending its State plan in accordance with proposed Sec.  441.45(a)(5).

The amendment must (1) describe the rehabilitative services proposed to

be furnished, (2) specify the provider type and provider qualifications

that are reasonably related to each of the rehabilitative services, and

(3) specify the methodology under which rehabilitation providers would

be paid.

2. Limitations for Rehabilitative Services

    In Sec.  441.45(b)(1) through (b)(8) we set forth limitations on

coverage of rehabilitative services in this proposed rule.

    We propose in Sec.  441.45(b)(1) that coverage of rehabilitative

services would not include services that are furnished through a non-

medical program as either a benefit or administrative activity,

including programs other than Medicaid, such as foster care, child

welfare, education, child care, vocational and prevocational training,

housing, parole and probation, juvenile justice, or public

guardianship. We also propose in Sec.  441.45(b)(1) that coverage of

rehabilitative services would not include services that are intrinsic

elements of programs other than Medicaid.

    It should be noted however, that enrollment in these non-medical

programs does not affect eligibility for Title XIX services.

Rehabilitation services may be covered by Medicaid if they are not the

responsibility of other programs and if all applicable requirements of

the Medicaid program are met. Medicaid rehabilitative services must be

coordinated with, but do not include, services furnished by other

programs that are focused on social or educational development goals

and are available as part of other services or programs. Further,

Medicaid rehabilitation services must be available for all participants

based on an identified medical need and otherwise would have been

provided to the individual outside of the foster care, juvenile

justice, parole and probation systems and other non-Medicaid systems.

Individuals must have free choice of providers and all willing and

qualified providers must be permitted to enroll in Medicaid.

    For instance, therapeutic foster care is a model of care, not a

medically necessary service defined under Title XIX of the Act. States

have used it as an umbrella to package an array of services, some of

which may be medically necessary services, some of which are not. In

order for a service to be reimbursable by Medicaid, states must

specifically define all of the services that are to be provided,

provider qualifications, and payment methodology. It is important to

note that provider qualifications for those who furnish care to

children in foster care must be the same as provider qualifications for

those who furnish the same care to children not in foster care.

Examples of therapeutic foster care components that would not be

Medicaid coverable services include provider recruitment, foster parent

training and other such services that are the responsibility of the

foster care system.

    In Sec.  441.45(b)(2), we propose to exclude FFP for expenditures

for habilitation services including those provided to individuals with

mental retardation or ``related conditions'' as defined in the State

Medicaid Manual Sec.  4398. Physical impairments and mental health and/

or substance related disorder are not considered ``related conditions''

and are therefore medical conditions for which rehabilitation services

may be appropriately provided. As a matter of general usage in the

medical community, there is a distinction between the terms

``habilitation'' and ``rehabilitation.'' Rehabilitation refers to

measures used to restore individuals to their best functional levels.

The emphasis in covering rehabilitation services is the restoration of

a functional ability. Individuals receiving rehabilitation services

must have had the capability to perform an activity in the past rather

than to actually have performed the activity. For example, a person may

not have needed to drive a car in the past, but may have had the

capability to do so prior to having the disability.

 

[[Page 45206]]

 

Habilitation typically refers to services that are for the purpose of

helping persons acquire new functional abilities. Current Medicaid

policy explicitly covers habilitation services in two ways: (1) When

provided in an intermediate care facility for persons with mental

retardation (ICF/MR); or (2) when covered under sections 1915(c), (d),

or (i) of the Act as a home and community-based service. Habilitation

services may also be provided under some 1905(a) service authorities

such as Physician services defined at 42 CFR 440.50, Therapy services

defined at 42 CFR 440.110 (such as, Physical Therapy, Occupational

Therapy, and Speech/Language/Audiology Therapy), and Medical or other

remedial care provided by licensed practitioners, defined at 42 CFR

440.60. Habilitative services can also be provided under the 1915(i)

State Plan Home and Community Based Services pursuant to the Deficit

Reduction Act of 2005. In the late 1980s, the Congress responded to

State concerns about disallowances for habilitation services provided

under the State's rehabilitative services benefit by passing section

6411(g) of the OBRA 89. This provision prohibited us from taking

adverse actions against States with approved habilitation provisions

pending the issuance of a regulation that ``specifies types of day

habilitation services that a State may cover under paragraphs (9)

[clinic services] or (13) [rehabilitative services] of section 1905(a)

of the Act on behalf of persons with mental retardation or with related

conditions.'' Accordingly, this regulation would specify that all such

habilitation services would not be covered under sections 1905(a)(9) or

1905(a)(13) of the Act. If this regulation is issued in final form, the

protections provided to certain States by section 6411(g) of OBRA 89

for day habilitation services will no longer be in force. We intend to

provide for a delayed compliance date so that States will have a

transition period of the lesser of 2 years or 1 year after the close of

the first regular session of the State legislature that begins after

this regulation becomes final before we will take enforcement action.

This transition period will permit States an opportunity to transfer

coverage of habilitation services from the rehabilitation option into

another appropriate Medicaid authority. We are available to States as

needed for technical assistance during this transition period.

    In Sec.  441.45(b)(3), we propose to provide that rehabilitative

services would not include recreational and social activities that are

not specifically focused on the improvement of physical or mental

health impairment and achievement of a specific rehabilitative goal

specified in the rehabilitation plan, and provided by a Medicaid

qualified provider recognized under State law. We would also specify in

this provision that rehabilitative services would not include personal

care services; transportation; vocational and prevocational services;

or patient education not related to the improvement of physical or

mental health impairment and achievement of a specific rehabilitative

goal specified in the rehabilitation plan. The first two of these

services may be otherwise covered under the State plan. But these

services are not primarily focused on rehabilitation, and thus do not

meet the definition of medical or remedial services for rehabilitative

purposes that would be contained in Sec.  440.130(d)(1).

    It is possible that some recreational or social activities are

reimbursable as rehabilitative services if they are provided for the

purpose allowed under the benefit and meet all the requirements

governing rehabilitative services. For example, in one instance the

activity of throwing a ball to an individual and having her/him throw

it back, may be a recreational activity. In another instance, the

activity may be part of a program of physical therapy that is provided

by, or under the direction of, a qualified therapist for the purpose of

restoring motor skills and balance in an individual who has suffered a

stroke. Likewise, for an individual suffering from mental illness, what

may appear to be a social activity may in fact be addressing the

rehabilitation goal of social skills development as identified in the

rehabilitation plan. The service would need to be specifically related

to an identified rehabilitative goal as documented in the

rehabilitation plan with specific time-limited treatment goals and

outcomes. The rehabilitative service would further need to be provided

by a qualified provider, be documented in the case record, and meet all

requirements of this proposed regulation.

    When personal care services are provided during the course of the

provision of a rehabilitative service, they are an incidental activity

and separate payment may not be made for the performance of the

incidental activity. For example, an individual recovering from the

effects of a stroke may receive occupational therapy services from a

qualified occupational therapy provider under the rehabilitation option

to regain the capacity to feed himself or herself. If during the course

of those services the individual's clothing becomes soiled and the

therapist assists the individual with changing his or her clothing, no

separate payment may be made for assisting the individual with dressing

under the rehabilitation option. However, FFP may be available for

optional State plan personal care services under Sec.  440.167 if

provided by an enrolled, qualified personal care services provider.

    Similarly, transportation is not within the scope of the definition

of rehabilitative services proposed by this regulation since the

transportation service itself does not result in the maximum reduction

of a physical or mental disability and restoration of the individual to

the best possible functional level. However, transportation is a

Medicaid covered service and may be billed separately as a medical

assistance service under Sec.  440.170, if provided by an enrolled,

qualified provider, or may be provided under the Medicaid program as an

administrative activity necessary for the proper and efficient

administration of the State's Medicaid program.

    Generally, vocational services are those that teach specific skills

required by an individual to perform tasks associated with performing a

job. Prevocational services address underlying habilitative goals that

are associated with performing compensated work. To the extent that the

primary purpose of these services is to help individuals acquire a

specific job skill, and are not provided for the purpose of reducing

disability and restoring a person to a previous functional level, they

would not be construed as covered rehabilitative services. For example,

teaching an individual to cook a meal to train for a job as a chef

would not be covered, whereas, teaching an individual to cook in order

to re-establish the use of her or his hands or to restore living skills

may be coverable. While it may be possible for Medicaid to cover

prevocational services when provided under the section 1915(c) of the

Act, home and community based services waiver programs, funding for

vocational services rests with other, non-Medicaid Federal and State

funding sources.

    Similarly, the purpose of patient education is one important

determinant to whether the activity is a rehabilitative activity

covered under Sec.  440.130(d). While taking classes in an academic

setting may increase an individual's integration into the community and

enable the individual to learn social skills, the primary purpose of

this activity is academic enhancement.

 

[[Page 45207]]

 

Thus, patient education in an academic setting is not covered under the

Medicaid rehabilitation option. On the other hand, some patient

education directed towards a specific rehabilitative therapy service

may be provided for the purpose of equipping the individual with

specific skills that will decrease disability and restore the

individual to a previous functioning level. For example, an individual

with a mental disorder that manifests with behavioral difficulties may

need anger management training to restore his or her ability to

interact appropriately with others. These services may be covered under

the rehabilitation option if all of the requirements of this regulation

are met.

    In Sec.  441.45(b)(4), we propose to exclude payment for services,

including services that are rehabilitative services that are provided

to inmates living in the secure custody of law enforcement and residing

in a public institution. An individual is considered to be living in

secure custody if serving time for a criminal offense in, or confined

involuntarily to, State or Federal prisons, local jails, detention

facilities, or other penal facilities. A facility is a public

institution when it is under the responsibility of a governmental unit

or over which a governmental unit exercises administrative control.

Rehabilitative services could be reimbursed on behalf of Medicaid-

eligible individuals paroled, on probation, on home release, in foster

care, in a group home, or other community placement, that are not part

of the public institution system, when the services are identified due

to a medical condition targeted under the State's Plan, are not used in

the administration of other non-medical programs.

    We also propose to exclude payment for services that are provided

to residents of an institution for mental disease (IMD), including

residents of a community residential treatment facility of over 16

beds, that is primarily engaged in providing diagnosis, treatment, or

care of persons with mental illness, and that does not meet the

requirements at Sec.  440.160. It appears that in the past, certain

States may have provided services under the rehabilitation option to

these individuals. Our proposed exclusion of FFP for rehabilitative

services provided to these populations is consistent with the statutory

requirements in paragraphs (A) and (B) following section 1905(a)(28) of

the Act. The statute indicates that ``except as otherwise provided in

paragraph (16), such term [medical assistance] does not include--(A)

Any such payments with respect to care or services for any individual

who is an inmate of a public institution; or (B) any such payments with

respect to care or services for any individual who has not attained 65

years and who is a patient in an IMD.'' Section 1905(a)(16) of the Act

defines as ``medical assistance'' ``* * * inpatient psychiatric

hospital services for individuals under age 21 * * *''. The Secretary

has defined the term ``inpatient psychiatric hospital services for

individuals under age 21'' in regulations at Sec.  440.160 to include

``a psychiatric facility which is accredited by the Joint Commission on

Accreditation of Healthcare Organizations, the Council on Accreditation

of Services for Families and Children, the Commission on Accreditation

of Rehabilitation Facilities, or by any other accrediting organization,

with comparable standards, that is recognized by the State.'' Thus, the

term ``inpatient psychiatric hospital services for individuals under

age 21'' includes services furnished in accredited children's

psychiatric residential treatment facilities that are not hospitals.

The rehabilitative services that are provided by the psychiatric

hospital or accredited psychiatric residential treatment facility

(PRTF) providing inpatient psychiatric services for individuals under

age 21 to its residents would be reimbursed under the benefit for

inpatient psychiatric services for individuals under age 21 (often

referred to as the ``psych under 21'' benefit), rather than under the

rehabilitative services benefit.

    In Sec.  441.45(b)(6), we propose to exclude expenditures for room

and board from payment under the rehabilitative services option. While

rehabilitative services may be furnished in a residential setting that

is not an IMD, the benefit provided by section 1905(a)(13) of the Act

is primarily intended for community based services. Thus, when

rehabilitative services are provided in a residential setting, such as

in a residential substance abuse treatment facility of less than 17

beds, delivered by qualified providers, only the costs of the specific

rehabilitative services will be covered.

    In Sec.  441.45(b)(7), we propose to preclude payment for services

furnished for the rehabilitation of an individual who is not Medicaid

eligible. This provision reinforces basic program requirements found in

section 1905(a) of the Act that require medical assistance to be

furnished only to eligible individuals. An ``eligible individual'' is a

person who is eligible for Medicaid and requires rehabilitative

services as defined in the Medicaid State plan at the time the services

are furnished.

    The provision of rehabilitative services to non-Medicaid eligible

individuals cannot be covered if it relates directly to the non-

eligible individual's care and treatment. However, effective

rehabilitation of eligible individuals may require some contact with

non-eligible individuals. For instance, in developing the

rehabilitation plan for a child with a mental illness, it may be

appropriate to include the child's parents, who are not eligible for

Medicaid, in the process. In addition, counseling sessions for the

treatment of the child might include the parents and other non-eligible

family members. In all cases, in order for a service to be a Medicaid

coverable service, it must be provided to, or directed exclusively

toward, the treatment of the Medicaid eligible individual.

    Thus, contacts with family members for the purpose of treating the

Medicaid eligible individual may be covered by Medicaid. If these other

family members or other individuals also are Medicaid eligible and in

need of the services covered under the State's rehabilitation plan,

Medicaid could pay for the services furnished to them.

    In Sec.  441.45(b)(8), we propose that FFP would only be available

for claims for services provided to a specific individual that are

documented in an individual's case record.

    We will work with States to implement this rule in a timely fashion

using existing monitoring and compliance authority.

 

III. Collection of Information Requirements

 

    Under the Paperwork Reduction Act of 1995, we are required to

provide 60-day notice in the Federal Register and solicit public

comment before a collection of information requirement is submitted to

the Office of Management and Budget (OMB) for review and approval. In

order to fairly evaluate whether an information collection should be

approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act

of 1995 requires that we solicit comment on the following issues:

     The need for the information collection and its usefulness

in carrying out the proper functions of our agency.

     The accuracy of our estimate of the information collection

burden.

     The quality, utility, and clarity of the information to be

collected.

     Recommendations to minimize the information collection

burden on the affected public, including automated collection

techniques.

 

[[Page 45208]]

 

    We are soliciting public comment on each of these issues for the

following sections of this document that contain information collection

requirements:

 

Section 440.130 Diagnostic, Screening, Preventative, and Rehabilitative

Services

 

    This section outlines the scope of service for rehabilitative

services provided by States. The services discussed in this section

must be provided under a written rehabilitation plan as defined in

Sec.  440.130(d)(1)(v). Specifically, Sec.  440.130(d)(3) states that

the written rehabilitation plan must meet the following requirements:

    (i) Be based on a comprehensive assessment of an individual's

rehabilitation needs including diagnoses and presence of a functional

impairment in daily living.

    (ii) Be developed by a qualified provider(s) working within the

State scope of practice act with input from the individual,

individual's family, the individual's authorized health care decision

maker and/or persons of the individual's choosing.

    (iii) Ensure the active participation of the individual,

individual's family, the individual's authorized health care decision

maker and/or persons of the individual's choosing in the development,

review, and modification of these goals and services.

    (iv) Specify the individual's rehabilitation goals to be achieved

including recovery goals for persons with mental illnesses or substance

related disorders.

    (v) Specify the physical impairment, mental health and/or substance

related disorder that is being addressed.

    (vi) Identify the medical and remedial services intended to reduce

the identified physical impairment, mental health and/or substance

related disorder.

    (vii) Identify the methods that will be used to deliver services.

    (viii)Specify the anticipated outcomes.

    (ix) Indicate the frequency and duration of the services.

    (x) Be signed by the individual responsible for developing the

rehabilitation plan.

    (xi) Indicate the anticipated provider(s) of the service(s) and the

extent to which the services may be available from alternate

provider(s) of the same service.

    (xii) Specify a timeline for reevaluation of the plan, based on the

individual's assessed needs and anticipated progress, but not longer

than one year.

    (xiii) Be reevaluated with the involvement of the beneficiary,

family or other responsible individuals.

    (xiv) Be reevaluated including a review of whether the goals set

forth in the plan are being met and whether each of the services

described in the plan has contributed to meeting the stated goals. If

it is determined that there has been no measurable reduction of

disability and restoration of functional level, any new plan would need

to pursue a different rehabilitation strategy including revision of the

rehabilitative goals, services and/or methods.

    (xv) Document that the individual or representative participated in

the development of the plan, signed the plan, and received a copy of

the rehabilitation plan.

    (xvi) Document that the services have been determined to be

rehabilitative services consistent with the regulatory definition.

    The burden associated with the requirements in this section is the

time and effort put forth by the provider to gather the information and

develop a specific written rehabilitation plan. While these

requirements are subject to the PRA, we believe they meet the exemption

requirements for the PRA found at 5 CFR 1320.3(b)(2), and as such, the

burden associated with these requirements is exempt.

 

Section 441.45 Rehabilitative Services

 

    Section 441.45(a)(3) requires that providers maintain case records

that contain a copy of the rehabilitation plan for all individuals.

    The burden associated with these requirements is the time and

effort put forth by the provider to maintain the case records. While

these requirements are subject to the PRA, we believe they meet the

exemption requirements for the PRA found at 5 CFR 1320.3(b)(2), and as

such, the burden associated with these requirements is exempt.

    If you comment on these information collection and recordkeeping

requirements, please mail copies directly to the following:

 

Centers for Medicare & Medicaid Services, Office of Strategic

Operations and Regulatory Affairs, Regulations Development Group, Attn:

Melissa Musotto [CMS-2261-P], Room C4-26-05, 7500 Security Boulevard,

Baltimore, MD 21244-1850; and

Office of Information and Regulatory Affairs, Office of Management and

Budget, Room 10235, New Executive Office Building, Washington, DC

20503, Attn: Katherine Astrich, CMS Desk Officer, [CMS-1321-P],

katherine_astrich@omb.eop.gov. Fax (202) 395-6974.

 

 

IV. Response to Comments

 

    Because of the large number of public comments we normally receive

on Federal Register documents, we are not able to acknowledge or

respond to them individually. We will consider all comments we receive

by the date and time specified in the DATES section of this preamble,

and, when we proceed with a final document, we will respond to the

comments in that document.

 

V. Regulatory Impact Analysis

 

A. Overall Impact

 

    We have examined the impacts of this rule as required by Executive

Order 12866 (September 1993, Regulatory Planning and Review), the

Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),

section 1102(b) of the Social Security Act, the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.

    Executive Order 12866 (as amended by Executive Order 13258, which

merely reassigns responsibility of duties) directs agencies to assess

all costs and benefits of available regulatory alternatives and, if

regulation is necessary, to select regulatory approaches that maximize

net benefits (including potential economic, environmental, public

health and safety effects, distributive impacts, and equity). A

regulatory impact analysis (RIA) must be prepared for major rules with

economically significant effects ($100 million or more in any 1 year).

This is a major rule because of the size of the anticipated reduction

in Federal financial participation that is estimated to have an

economically significant effect of more than $100 million in each of

the Federal fiscal years 2008 through 2012.

    The RFA requires agencies to analyze options for regulatory relief

of small businesses. For purposes of the RFA, small entities include

small businesses, nonprofit organizations, and small governmental

jurisdictions. Most hospitals and most other providers and suppliers

are small entities, either by nonprofit status or by having revenues of

$6.5 million to $31.5 million in any 1 year. The Secretary certifies

that this major rule would not have a direct impact on providers of

rehabilitative services that furnish services pursuant to section

1905(a)(13) of the Act. The rule would directly affect states and we do

not know nor can we predict the manner in which states would adjust or

respond to the provisions of this rule. CMS is unable to determine the

 

[[Page 45209]]

 

percentage of providers of rehabilitative services that are considered

small businesses according to the Small Business Administration's size

standards with total revenues of $6.5 million to $31.5 million or less

in any 1 year. Individuals and States are not included in the

definition of a small entity. In addition, section 1102(b) of the Act

requires us to prepare a regulatory impact analysis if a rule may have

a significant impact on the operations of a substantial number of small

rural hospitals. This analysis must conform to the provisions of

section 603 (proposed documents) of the RFA. For purposes of section

1102(b) of the Act, we define a small rural hospital as a hospital that

is located outside of a Metropolitan Statistical Area for Medicaid

payment regulations and has fewer than 100 beds. The Secretary

certifies that this major rule would not have a direct impact on small

rural hospitals. The rule would directly affect states and we do not

know nor can we predict the manner in which states would adjust or

respond to the provisions of this rule.

    Section 202 of the Unfunded Mandates Reform Act (UMRA) of 1995 also

requires that agencies assess anticipated costs and benefits before

issuing any rule whose mandates require spending in any 1 year of $100

million in 1995 dollars, updated annually for inflation. That threshold

level is currently approximately $120 million. Since this rule would

not mandate spending in any 1 year of $120 million or more, the

requirements of the UMRA are not applicable.

    Executive Order 13132 establishes certain requirements that an

agency must meet when it promulgates a proposed rule (and subsequent

final rule) that imposes substantial direct requirement costs on State

and local governments, preempts State law, or otherwise has Federalism

implications. Since this rule would not impose any costs on State or

local governments, preempt State law, or otherwise have Federalism

implications, the requirements of E.O. 13132 are not applicable.

 

B. Anticipated Effects

 

    FFP will be available for rehabilitative services for treatment of

physical, mental health, or substance-related disorder rehabilitation

treatment if the State elects to provide those services through the

approved State plan. Individuals retain the right to select among

qualified providers of rehabilitative services. However, because FFP

will be excluded for rehabilitative services that are included in other

Federal, State and local programs, it is estimated that Federal

Medicaid spending on rehabilitative services would be reduced by

approximately $180 million in FY 2008 and would be reduced by $2.2

billion between FY 2008 and FY 2012. This reduction in spending is

expected to occur because FFP for rehabilitative services would no

longer be paid to inappropriate other third parties or other Federal,

State, or local programs.

    The estimated impact on Federal Medicaid spending was calculated

starting with an estimate of rehabilitative service spending that may

be subject to this rule. This estimate was developed after consulting

with several experts, as data for rehabilitative services, particularly

as it would apply to this rule, is limited. Given this estimate, the

actuaries discounted this amount to account for four factors: (1) The

ability of CMS to effectively identify the rehabilitative services

spending that would be subject to this proposal; (2) the effectiveness

of CMS's efforts to implement this rule and the potential that some

identified rehabilitative services spending may still be permissible

under the rule; (3) the change in States' plans that may regain some of

the lost Federal funding; and (4) the length of time for CMS to fully

implement the rule and review all States' plans.

    The actual impact to the Federal Medicaid program may be different

than the estimate to the extent that the estimate of the amount of

rehabilitative services spending subject to this rule is different than

the actual amount and to the extent that the effectiveness of the rule

is greater than or less than assumed. Because a comprehensive review of

these rehabilitative services had not been conducted at the time of

this estimate and because we do not routinely collect data on spending

for rehabilitative services, particularly as it relates to this rule,

there is a significantly wide range of possible impacts.

    Thus, we are unable to determine what fiscal impact the publication

of this rule would have on consumers, individual industries, Federal,

State, or local government agencies or geographic regions under

Executive Order 12866. We invite public comment on the potential impact

of the rule.

 

C. Alternatives Considered

 

    This proposed rule would amend the definition of rehabilitative

services to provide for important individual protections and to clarify

that Medicaid rehabilitative services must be coordinated with but do

not include services furnished by other programs that are focused on

social or educational development goals and available as part of other

services or programs. We believe this proposed rule is the best

approach to clarifying the covered rehabilitative services, and also

because all stakeholders will have the opportunity to comment on the

proposed rule. These comments will then be considered before the final

document is published.

    In considering regulatory options, we considered requiring States

to license all providers as an alternative to only requiring that

providers to be qualified as defined by the State. However we believe

that giving States the flexibility to determine how providers are

credentialed allows for necessary flexibility to States to consider a

wide range of provider types necessary to cover a variety of

rehabilitation services. We believe this flexibility will result in

decreases in administrative and service costs.

    We also considered restricting the rule to only include participant

protections but not explicitly prohibiting FFP for services that are

intrinsic elements of other non-Medicaid programs. Had we not

prohibited FFP for services that are intrinsic elements of other

programs, States would continue to provide non-Medicaid services to

participants, the result would have been a less efficient use of

Medicaid funding because increased Medicaid spending would not result

in any increase in services to beneficiaries. Instead, increased

Medicaid funding would have simply replaced other sources of funding.

 

D. Accounting Statement and Table

 

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf

), in the table below, we

 

have prepared an accounting statement showing the classification of the

savings associated with the provisions of this proposed rule. This

table provides our best estimate of the savings to the Federal

Government as a result of the changes presented in this proposed rule

that Federal Medicaid spending on rehabilitative services would be

reduced by approximately $180 million in FY 2008 and would be reduced

by $2.24 billion between FY 2008 and FY 2012. All savings are

classified as transfers from the Federal Government to State

Government. These transfers represent a reduction in the federal share

of Medicaid spending once the rule goes into effect, as it would limit

States from claiming Medicaid reimbursement for

 

[[Page 45210]]

 

rehabilitation services that could be covered through other programs.

 

               Accounting Statement: Classification of Estimated Savings, From FY 2008 to FY 2012

                                                  [In millions]

----------------------------------------------------------------------------------------------------------------

                                                      Primary                     Units discount

                    Category                         estimates      Year dollar        rate       Period covered

----------------------------------------------------------------------------------------------------------------

Federal Annualized Monetized ($millions/year)...           443.4            2008              7%       2008-2012

                                                  ..............  ..............  ..............  ..............

                                                           441.6            2008              3%       2008-2012

                                                  ..............  ..............  ..............  ..............

                                                             448            2008              0%       2008-2012

                                                 ---------------------------------------------------------------

From Whom to Whom?..............................              Federal Government to State Government

----------------------------------------------------------------------------------------------------------------

 

    Column 1: Category--Contains the description of the different

impacts of the rule; it could include monetized, quantitative but not

monetized, or qualitative but not quantitative or monetized impacts; it

also may contain unit of measurement (such as, dollars). In this case,

the only impact is the Federal annualized monetized impact of the rule.

    Column 2: Primary Estimate--Contains the quantitative or

qualitative impact of the rule for the respective category of impact.

Monetized amounts are generally shown in real dollar terms. In this

case, the federalized annualized monetized primary estimate represents

the equivalent amount that, if paid (saved) each year over the period

covered, would result in the same net present value of the stream of

costs (savings) estimated over the period covered.

    Column 3: Year Dollar--Contains the year to which dollars are

normalized; that is, the first year that dollars are discounted in the

estimate.

    Column 4: Unit Discount Rate--Contains the discount rate or rates

used to estimate the annualized monetized impacts. In this case, three

rates are used: 7 percent; 3 percent; 0 percent.

    Column 5: Period Covered--Contains the years for which the estimate

was made.

    Rows: The rows contain the estimates associated with each specific

impact and each discount rate used.

    ``From Whom to Whom?''--In the case of a transfer (as opposed to a

change in aggregate social welfare as described in the OMB Circular),

this section describes the parties involved in the transfer of costs.

In this case, costs previously paid for by the Federal Government would

be transferred to the State Governments. The table may also contain

minimum and maximum estimates and sources cited. In this case, there is

only a primary estimate and there are no additional sources for the

estimate.

    Estimated Savings--The following table shows the discounted costs

(savings) for each discount rate and for each year over the period

covered. ``Total'' represents the net present value of the impact in

the year the rule takes effect. These numbers represent the anticipated

annual reduction in Federal Medicaid spending under this rule.

 

                                                       Estimated Savings, From FY 2008 to FY 2012

                                                                      [In millions]

--------------------------------------------------------------------------------------------------------------------------------------------------------

                Discount rate  (percent)                       2008            2009            2010            2011            2012            Total

--------------------------------------------------------------------------------------------------------------------------------------------------------

0.......................................................             180             360             520             570             610           2,288

3.......................................................             175             339             476             506             526           2,069

7.......................................................             168             314             424             435             435           1,822

--------------------------------------------------------------------------------------------------------------------------------------------------------

 

E. Conclusion

 

    For these reasons, we are not preparing analyses for either the RFA

or section 1102(b) of the Act because a comprehensive review of these

rehabilitative services had not been conducted at the time of this

estimate and because we do not routinely collect data on spending for

rehabilitative services. Accordingly, there is a significantly wide

range of possible impacts due to this rule. As indicated in the

Estimated Savings table above, we project an estimated savings of $180

million in FY 2008, $360 million in FY 2009, $520 million in FY 2010,

$570 million in FY 2011, and $610 million in FY 2012. This reflects a

total estimated savings of $2.240 billion dollars for FY 2008 through

FY 2012. We invite public comment on the potential impact of this rule.

    In accordance with the provisions of Executive Order 12866, this

regulation was reviewed by the Office of Management and Budget.

 

List of Subjects

 

42 CFR Part 440

 

    Grant programs--health, Medicaid.

 

42 CFR Part 441

 

    Family planning, Grant programs--health, Infants and children,

Medicaid, Penalties, Prescription drugs, Reporting and recordkeeping

requirements.

 

    For the reasons set forth in the preamble, the Centers for Medicare

& Medicaid Services proposes to amend 42 CFR chapter IV as set forth

below:

 

PART 440--SERVICES: GENERAL PROVISIONS

 

    1. The authority citation for part 440 continues to read as

follows:

 

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C.

1302).

 

    2. Section 440.130 is amended by revising paragraph (d) to read as

follows:

 

Sec.  440.130 Diagnostic, screening, preventative, and rehabilitative

services.

 

* * * * *

 

[[Page 45211]]

 

    (d) Rehabilitative Services--(1) Definitions. For purposes of this

subpart, the following definitions apply:

    (i) Recommended by a physician or other licensed practitioner of

the healing arts means that a physician or other licensed practitioner

of the healing arts, based on a comprehensive assessment of the

individual, has--

    (A) Determined that receipt of rehabilitative services would result

in reduction of the individual's physical or mental disability and

restoration to the best possible functional level of the individual;

and

    (B) Recommended the rehabilitative services to achieve specific

individualized goals.

    (ii) Other licensed practitioner of the healing arts means any

health practitioner or practitioner of the healing arts who is licensed

in the State to diagnose and treat individuals with the physical or

mental disability or functional limitations at issue, and operating

within the scope of practice defined in State law.

    (iii) Qualified providers of rehabilitative services means

individuals who meet any applicable provider qualifications under

Federal law that would be applicable to the same service when it is

furnished under other Medicaid benefit categories, qualifications under

applicable State scope of practice laws, and any additional

qualifications set forth in the Medicaid State plan. These

qualifications may include minimum age requirements, education, work

experience, training, credentialing, supervision and licensing

requirements that are applied uniformly. Provider qualifications must

be documented in the State plan and be reasonable given the nature of

the service provided and the population served. Individuals must have

free choice of providers and all willing and qualified providers must

be permitted to enroll in Medicaid.

    (iv) Under the direction of means that for physical therapy,

occupational therapy, and services for individuals with speech, hearing

and language disorders (see Sec.  440.110, ``Inpatient hospital

services, other than services in an institution for mental diseases'')

the Medicaid qualified therapist providing direction is a licensed

practitioner of the healing arts qualified under State law to diagnose

and treat individuals with the disability or functional limitations at

issue, is working within the scope of practice defined in State law and

is supervising each individual's care. The supervision must include, at

a minimum, face-to-face contact with the individual initially and

periodically as needed, prescribing the services to be provided, and

reviewing the need for continued services throughout the course of

treatment. The qualified therapist must also assume professional

responsibility for the services provided and ensure that the services

are medically necessary. Therapists must spend as much time as

necessary directly supervising services to ensure beneficiaries are

receiving services in a safe and efficient manner in accordance with

accepted standards of practice. Moreover, documentation must be kept

supporting the supervision of services and ongoing involvement in the

treatment. Note that this definition applies specifically to providers

of physical therapy, occupational therapy, and services for individuals

with speech, hearing and language disorders. This language is not meant

to exclude appropriate supervision arrangements for other

rehabilitative services.

    (v) Rehabilitation plan means a written plan that specifies the

physical impairment, mental health and/or substance related disorder to

be addressed, the individualized rehabilitation goals and the medical

and remedial services to achieve those goals. The plan is developed by

a qualified provider(s) working within the State scope of practice act,

with input from the individual, individual's family, the individual's

authorized decision maker and/or of the individual's choosing and also

ensures the active participation of the individual, individual's

family, individual's authorized decision maker and/or of the

individual's choosing in the development, review, and modification of

the goals and services. The plan must document that the services have

been determined to be rehabilitative services consistent with the

regulatory definition. The plan must have a timeline, based on the

individual's assessed needs and anticipated progress, for reevaluation

of the plan, not longer than one year. The plan must be reasonable and

based on the individual's condition(s) and on general standards of

practice for provision of rehabilitative services to an individual with

the individual's condition(s).

    (vi) Restorative services means services that are provided to an

individual who has had a functional loss and has a specific

rehabilitative goal toward regaining that function. The emphasis in

covering rehabilitation services is on the ability to perform a

function rather than to actually have performed the function in the

past. For example, a person may not have needed to take public

transportation in the past, but may have had the ability to do so prior

to having the disability. Rehabilitation goals are often contingent on

the individual's maintenance of a current level of functioning. In

these instances services that provide assistance in maintaining

functioning may be considered rehabilitative only when necessary to

help an individual achieve a rehabilitation goal defined in the

rehabilitation plan. Services provided primarily in order to maintain a

level of functioning in the absence of a rehabilitation goal are not

within the scope of rehabilitation services.

    (vii) Medical services means services specified in the

rehabilitation plan that are required for the diagnosis, treatment, or

care of a physical or mental disorder and are recommended by a

physician or other licensed practitioner of the healing arts within the

scope of his or her practice under State law. Medical services may

include physical therapy, occupational therapy, speech therapy, and

mental health and substance-related disorder rehabilitative services.

    (viii) Remedial services means services that are intended to

correct a physical or mental disorder and are necessary to achieve a

specific rehabilitative goal specified in the individual's

rehabilitation plan.

    (2) Scope of services. Except as otherwise provided under this

subpart, rehabilitative services include medical or remedial services

recommended by a physician or other licensed practitioner of the

healing arts, within the scope of his practice under State law, for

maximum reduction of physical or mental disability and restoration of a

individual to the best possible functional level. Rehabilitative

services may include assistive devices, medical equipment and supplies,

not otherwise covered under the plan, which are determined necessary to

the achievement of the individual's rehabilitation goals.

Rehabilitative services do not include room and board in an institution

or community setting.

    (3) Written rehabilitation plan. The written rehabilitation plan

shall be reasonable and based on the individual's condition(s) and on

the standards of practice for provision of rehabilitative services to

an individual with the individual's condition(s). In addition, the

written rehabilitation plan must meet the following requirements:

    (i) Be based on a comprehensive assessment of an individual's

rehabilitation needs including diagnoses and presence of a functional

impairment in daily living.

    (ii) Be developed by a qualified provider(s) working within the

State scope of practice act with input from the individual,

individual's family, the individual's authorized health care

 

[[Page 45212]]

 

decision maker and/or persons of the individual's choosing.

    (iii) Follow guidance obtained through the active participation of

the individual, and/or persons of the individual's choosing (which may

include the individual's family and the individual's authorized health

care decision maker), in the development, review, and modification of

plan goals and services.

    (iv) Specify the individual's rehabilitation goals to be achieved,

including recovery goals for persons with mental health and/or

substance related disorders.

    (v) Specify the physical impairment, mental health and/or substance

related disorder that is being addressed.

    (vi) Identify the medical and remedial services intended to reduce

the identified physical impairment, mental health and/or substance

related disorder.

    (vii) Identify the methods that will be used to deliver services.

    (viii) Specify the anticipated outcomes.

    (ix) Indicate the frequency, amount and duration of the services.

    (x) Be signed by the individual responsible for developing the

rehabilitation plan.

    (xi) Indicate the anticipated provider(s) of the service(s) and the

extent to which the services may be available from alternate

provider(s) of the same service.

    (xii) Specify a timeline for reevaluation of the plan, based on the

individual's assessed needs and anticipated progress, but not longer

than one year.

    (xiii) Be reevaluated with the involvement of the individual,

family or other responsible individuals.

    (xiv) Be reevaluated including a review of whether the goals set

forth in the plan are being met and whether each of the services

described in the plan has contributed to meeting the stated goals. If

it is determined that there has been no measurable reduction of

disability and restoration of functional level, any new plan would need

to pursue a different rehabilitation strategy including revision of the

rehabilitative goals, services and/or methods.

    (xv) Document that the individual or representative participated in

the development of the plan, signed the plan, and received a copy of

the rehabilitation plan.

    (xvi) Document that the services have been determined to be

rehabilitative services consistent with the regulatory definition.

    (xvii) Include the individual's relevant history, current medical

findings, contraindications and identify the individual's care

coordination needs, if any, as needed to achieve the rehabilitation

goals.

    (4) Impairments to be addressed. For purposes of this section,

rehabilitative services include services provided to the Medicaid

eligible individual to address the individual's physical impairments,

mental health impairments, and/or substance-related disorder treatment

needs.

    (5) Settings. Rehabilitative services may be provided in a

facility, home, or other setting.

 

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC

SERVICES

 

    1. The authority citation for part 441 continues to read as

follows:

 

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C.

1302).

 

Subpart A--General Provisions

 

    2. A new Sec.  441.45 is added to subpart A to read as follows:

 

 

Sec.  441.45  Rehabilitative services.

 

    (a) If a State covers rehabilitative services, as defined in Sec. 

440.130(d) of this chapter, the State must meet the following

requirements:

    (1) Ensure that services are provided in accordance with Sec. 

431.50, Sec.  431.51, Sec.  440.230, and Sec.  440.240 of this chapter.

    (2) Ensure that rehabilitative services are limited to services

furnished for the maximum reduction of physical or mental disability

and restoration of the individual to their best possible functional

level.

    (3) Require that providers maintain case records that contain a

copy of the rehabilitation plan for all individuals.

    (4) For all individuals receiving rehabilitative services, require

that providers maintain case records that include the following:

    (i) A copy of the rehabilitative plan.

    (ii) The name of the individual.

    (iii) The date of the rehabilitative services provided.

    (iv) The nature, content, and units of the rehabilitative services.

    (v) The progress made toward functional improvement and attainment

of the individual's goals as identified in the rehabilitation plan and

case record.

    (5) Ensure the State plan for rehabilitative services includes the

following requirements:

    (i) Describes the rehabilitative services furnished.

    (ii) Specifies provider qualifications that are reasonably related

to the rehabilitative services proposed to be furnished.

    (iii) Specifies the methodology under which rehabilitation

providers are paid.

    (b) Rehabilitation does not include, and FFP is not available in

expenditures for, services defined in Sec.  440.130(d) of this chapter

if the following conditions exist:

    (1) The services are furnished through a non-medical program as

either a benefit or administrative activity, including services that

are intrinsic elements of programs other than Medicaid, such as foster

care, child welfare, education, child care, vocational and

prevocational training, housing, parole and probation, juvenile

justice, or public guardianship. Examples of services that are

intrinsic elements of other programs and that would not be paid under

Medicaid include, but are not limited to, the following:

    (i) Therapeutic foster care services furnished by foster care

providers to children, except for medically necessary rehabilitation

services for an eligible child that are clearly distinct from packaged

therapeutic foster care services and that are provided by qualified

Medicaid providers.

    (ii) Packaged services furnished by foster care or child care

institutions for a foster child except for medically necessary

rehabilitation services for an eligible child that are clearly distinct

from packaged therapeutic foster care services and that are provided by

qualified Medicaid providers.

    (iii) Adoption services, family preservation, and family

reunification services furnished by public or private social services

agencies.

    (iv) Routine supervision and non-medical support services provided

by teacher aides in school settings (sometimes referred to as

``classroom aides'' and ``recess aides'').

    (2) Habilitation services, including services for which FFP was

formerly permitted under the Omnibus Budget Reconciliation Act of 1989.

Habilitation services include ``services provided to individuals'' with

mental retardation or related conditions. (Most physical impairments,

and mental health and/or substance related disorders, are not included

in the scope of related conditions, so rehabilitation services may be

appropriately provided.)

    (3) Recreational or social activities that are not focused on

rehabilitation and not provided by a Medicaid qualified provider;

personal care services; transportation; vocational and prevocational

services; or patient education not related to reduction of physical or

mental disability and the restoration of an individual to his or her

best possible functional level.

 

[[Page 45213]]

 

    (4) Services that are provided to inmates living in the secure

custody of law enforcement and residing in a public institution. An

individual is considered to be living in secure custody if serving time

for a criminal offence in, or confined involuntarily to, public

institutions such as State or Federal prisons, local jails, detention

facilities, or other penal facilities. A facility is a public

institution when it is under the responsibility of a governmental unit;

or over which a governmental unit exercises administrative control.

Rehabilitative services could be reimbursed on behalf of Medicaid-

eligible individuals paroled, on probation, on home release, in foster

care, in a group home, or other community placement, that are not part

of the public institution system, when the services are identified due

to a medical condition targeted under the State's Plan, are not used in

the administration of other non-medical programs.

    (5) Services provided to residents of an institution for mental

disease (IMD) who are under the age of 65, including residents of

community residential treatment facilities with more than 16 beds that

do not meet the requirements at Sec.  440.160 of this chapter.

    (6) Room and board.

    (7) Services furnished for the treatment of an individual who is

not Medicaid eligible.

    (8) Services that are not provided to a specific individual as

documented in an individual's case record.

 

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical

Assistance Program)

 

    Dated: March 22, 2007.

Leslie V. Norwalk,

Acting Administrator, Centers for Medicare & Medicaid Services.

 

    Approved: July 12, 2007.

Michael O. Leavitt,

Secretary.

[FR Doc. 07-3925 Filed 8-8-07; 4:00 pm]

 

BILLING CODE 4120-01-P